FDA.reportPublic FDA data

30 Deg 4mm AC Arthroscope

Primary DI
00856164008181
Brand
30 Deg 4mm AC Arthroscope
Company
Poc
Model
5250-901
Device description
The POC endoscope is intended use for endoscopic viewing of internal surgery sites during minimally invasive surgery in the peritoneal cavity, thoracic cavity, and peritoneum. It is designed for use with endoscopic instrument control systems during laparoscopic and thoracoscopic surgical procedures.
Published
2021-03-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K945684000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945684000POC ARTHROSCOPE AND ACCESSORIESPrecision Optics Corp.1995-06-14HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856164008181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856164008181008561640081818561640081810856164008181

GMDN Terms#

Term, Definition table
TermDefinition
Rigid arthroscope, reusableAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the interior of a joint (e.g., knee, shoulder, elbow). It is inserted into the body through an artificial orifice created by an incision made during arthroscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is commonly used to examine structural damage to a joint, often from sports injuries. The arthroscope eyepiece is normally interfaced with a video camera. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
118244987
Device count
1
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0085616400800630 Deg 10mm AC Lap POC6713-9016713-8012021-03-23
008561640080130 Deg 10mm Laparoscope Assembly POC6711-9012021-03-23
008561640081670 Deg 5mm LENSLOCK AC Laparoscope5281-9002021-03-23
008561640081980 Deg 4mm AC Arthroscope5250-9022021-03-23
0085616400802030 Deg 5mm POC Laparoscope Assy6753-9012021-03-23
008561640080820 Deg 5mm POC AC Laparoscope Assy6751-9012021-03-23
008561640081430 Deg 10mm 425mm Lg, Laparoscope6761-9032021-03-23
0085616400815030 Deg 10mm 425mm Lg., Laparoscope6763-9042021-03-23
0085616400817418 Deg 5mm x 407mm Laparoscope8332-9002021-03-23

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